MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 19-9; TEST, CARBOHYDRATE ANTIGEN (CA19-9)

Catalog Number 11776193122

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous high results for three samples from the same patient tested for carbohydrate antigen 19-9 (ca 19-9) on an elecsys analyzer.All measurement results were reported outside of the laboratory.The first sample resulted as 225 u/ml when tested on an elecsys analyzer.The second sample resulted as 234 u/ml when tested on an elecsys analyzer on (b)(6) 2016.The third sample resulted as 240 u/ml when tested on an elecsys analyzer on (b)(6) 2016.The customer stated that the ca 19-9 results of this patient had been 20-25 u/ml for years, so the patient was tested at another site using an unknown test method, resulting with a value of 20 u/ml.The customer states that the patient had a comparable result obtained at an external laboratory and the linearity of measurements were found to be ok.The patient was not adversely affected.The model and serial number of the used elecsys analyzer was asked for, but not provided.A specific root cause could not be determined based on the provided information.A sample from the patient was requested for investigation, but there was not sufficient sample volume left over for investigation.The difference in ca 19-9 measurements using different assays may be caused by the different test principles used, different antibodies used, sample contamination, and different sample handling conditions.Also, no gold standard exists for ca 19-9, therefore different findings in different assays can occur.This limitation covered in product labeling.A general reagent or analyzer issue can be excluded based on the provided information.

Manufacturer Narrative

A new sample from the same patient was collected and tested for ca 19-9 on the customer's elecsys modular analyzer.The sample was then provided for investigation where it was tested on an e411 analyzer, a cobas e602 analyzer, and with the lumipulse method.It was asked, but it is not known if any erroneous results from this sample were reported outside of the laboratory.It was stated that no other tests for the patient indicated abnormal values.The sample initially resulted as 220 u/ml on (b)(6) 2016 when tested on the customer's elecsys modular analyzer.The sample was provided for investigation where it was tested on an e411 analyzer, resulting as 205.2 u/ml on (b)(6) 2016.During investigations, the sample was tested on a cobas e602 analyzer, resulting as 201.2 u/ml on (b)(6) 2016.The sample was also tested for ca 19-9 neuraminidase recovery on the cobas e602 analyzer on (b)(6) 2016, resulting as 201.2 u/ml "before" and 1.29 u/ml "after".During investigations, the sample was also tested using the lumipulse method, resulting as 159 u/ml on (b)(6) 2016.The patient was not adversely affected.The model and serial number of the elecsys modular analyzer used at the customer site was asked for, but not provided.The e411 analyzer used for investigation was serial number (b)(4).Ca 19-9 reagent lot 188632, with an expiration date of may 2017.The cobas 8000 analyzer used for investigation was serial number (b)(4).Ca 19-9 reagent lot 188632, with an expiration date of may 2017.It was stated that the patient stopped taking their lotriga medication for one week prior to going to another hospital, where the patient had a ca 19-9 value of approximately 20 u/ml.The results reported by the customer were reproducible and confirmed by lumipulse method.Investigations conclude that there is no indication of an interference factor within the sample affecting the elecsys ca 19-9 assay.The ca 19-9 concentration measured by the customer is rated to be the correct result.The reason for the high concentration is unknown.

• Brand Name: ELECSYS CA 19-9
• Type of Device: TEST, CARBOHYDRATE ANTIGEN (CA19-9)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5694195
• MDR Text Key: 46371777
• Report Number: 1823260-2016-00705
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050231
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11776193122
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1